The Electrode Store
by The Electrode Store United States EUDAMED
Ref 1021-KModel Disposable Cutaneous Surface Electrode
EMDN N010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081602202SURFDI74 | Date23 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Cutaneous Surface Electrode
- Model / Reference
- Disposable Cutaneous Surface Electrode, 1021-K
- Primary DI / UDI-DI
- 00816022023756
- Basic UDI-DI
- 081602202SURFDI74
- Direct Marketing DI
- 00816022023756
- EMDN Code
- N010101 Electromyographic electrodes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000036200
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from The Electrode Store
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 97ecfe04-7e8e-48f1-a08f-7977337951cb